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RAIN Sheath™ Transradial Introducer

by Cordis US Corp. 32 variants

Ref 506710N

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number07050320000000000000069D5 Basic UDI-DI 10705032082242UDI-DIDate5 Oct 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number10705032082242 UDI-DI Date17 Dec 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
RAIN Sheath™ Transradial Introducer EUDAMED
RAIN Sheath Transradial GUDID
Generic Name
Vascular catheter introduction set, nonimplantable
Device Name
Catheter Sheath Introducer - RAIN Sheath™ Transradial Introducer - Nitinol Mini Guidewire
Model / Ref / Catalog
506710N
Primary DI / UDI-DI
10705032082242
Basic UDI-DI
07050320000000000000069D5
FDA Product Code
DYB
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1340
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000020031
Authorised representative
Cordis Cashel IE-AR-000017793

Related devices

Category: Vascular catheter introduction set, nonimplantable

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →

Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Endocrine Disruptor
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No